Orthopedic devices and systems integrated with sensors and controlling devices

ABSTRACT

An orthopedic support and/or treatment system including a brace, sleeve, and/or insert, comprising a power subsystem; a sensor subsystem; an adjustment mechanism; a software subsystem; a communication subsystem; and a telemedicine subsystem. The orthopedic treatment system includes and communicates over a network to a remote controlling device. The remote control device can be a computer, a mobile device, or any other controller. The sensor subsystem communicates to the remote control device, which in turn can be used to control the adjustment mechanism to adjust a tension or compression of the brace or sleeve.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of U.S. patent applicationSer. No. 15/620,339, filed on 12 Jun. 2017, issued as U.S. Pat. No.11,065,142, and which claims the benefit of U.S. Provisional PatentApplication, Ser. No. 62/351,586, filed on 17 Jun. 2016. The co-pendingparent Patent Application is hereby incorporated by reference herein inits entirety and is made a part hereof, including but not limited tothose portions which specifically appear hereinafter.

BACKGROUND

Orthopedic treatment, namely physical therapy, pre-surgical, surgical,and post-surgical procedures, are affecting a continuously growingnumber of individuals. Regardless of the reason for this growth, be itsedentary lifestyle, heavy waste-line, increasing segment of agingpopulation or any other reason, society must tackle and meet thisgrowing demand for therapies that help individuals manage the healthconsequences of these trends.

Unfortunately, access to qualified orthopedic treatment facilities andpersonnel remains a concern. This is ever more so for remotely locatedand underserved population groups. To meet the clinical needs fororthopedic treatment for these groups, a significant advance would beorthopedic treatment methods incorporating “smart” technologies such astelemedicine and remote sensing technology.

However, despite advances in devices for orthopedic treatment, thereremains a need for integrating “smart” technology to address theorthopedic treatment needs. Such technology should support automatedfeedback to assist the patient in their treatment cycle. Thereadditionally is a continuing need to provide remote care for patients,providing the patients with easier access to their attending healthcareprofessional. Additionally, there is likewise a continuing need forproviding the attending healthcare professional with management anddiagnostic tools, thereby improving their ability to provide the highestof quality care for their patients, while driving down costs andimproving convenience.

SUMMARY

This invention provides a support or treatment system for the body, amethod implemented by the system, and encoded software instructionsexecutable by the system for implementing the system and method.Embodiments of the system of this invention include a wearable device,embodied as any number of braces or sleeves for different parts of thebody, such as sleeves and/or braces for support and/or treatment (e.g.,athletic and/or medical) of, without limitation, ankles, legs, knees,hips, shoulders, necks, torsos, backs, hands, wrists, fingers, elbows,or combinations thereof. In embodiments of this invention, the wearabledevice, also referred to herein as an orthopedic device or a treatmentdevice, is in communication over a network with a remote control device,typically including a data processor and a GUI for remote adjustmentand/or monitoring of the wearable device.

Embodiments of this invention provide a support and/or treatment systemincluding an orthopedic device adapted to be worn by a patient. Theorthopedic device includes an adjustment mechanism and a control unitincluding a processor each integrated with the orthopedic device. Thecontrol unit is in controlling combination with the adjustmentmechanism, such as to loosen or tighten components of the device. Thesystem includes a control device remote from the orthopedic device andconnected to the control unit over a network, such as to allow remotecontrol and monitoring of adjustments and the results. A sensorsubsystem is desirably integrated into the device to allow for themonitoring of the device and patient.

The invention further includes a support and/or treatment systemincluding a brace or sleeve including a support structure and aninterior cavity configured to receive a portion of a body. An adjustmentmechanism is in combination with the support structure, wherein theadjustment mechanism adjusts a tension in at least a portion of thesupport structure. A control unit including a processor is integratedwith the brace or sleeve and in control combination with the adjustmentmechanism to adjust the tension of the support structure. A controldevice remote from the brace or sleeve is connected to the control unitover a network, such as to allow remote control and monitoring ofadjustments and the results.

In embodiments of this invention the adjustment mechanism comprises arotating bar or rod and two motors each at an opposing end of therotating bar or rod and controllable by the control device via thecontrol unit. The rotating bar or rod can include a flexible centersection between two rigid end sections, and wherein the two motors areconfigured to rotate the rigid end sections in opposing rotationaldirections to twist the flexible center section to adjust the tensionwithin the support structure. The adjustable rod can provide foradjustable tension in a joint support, and can be useful, for example,in reducing or eliminating hyper-flexing of a knee, such as after a kneereplacement procedure.

In some embodiments of this invention, the adjustment mechanism furtherincludes at least one, and desirably a plurality of straps eachconnected at a first end to the rotating bar or rod and fixed at asecond end to the device, brace, or sleeve, wherein rotation of the bartightens or loosens the straps to adjust a tension of or about aninterior cavity of the device through which the body part(s) extend,thereby, for example, increasing a compression of the device on the bodypart(s).

In embodiments of this invention, the system includes a power subsystem;a sensor subsystem; a communication subsystem; a compression subsystem;a software subsystem; and a telemedicine subsystem. In presentlypreferred embodiments, the system further includes a remote controldevice. In various embodiments, the remote control device can be acomputer (such as, workstation, personal computer, tablet, etc.), amobile device (such as, a conventional or an intelligent cell phone) orany other controller. In some embodiments, the remote control device canbe configured as part of the sleeve or brace, or alternatively,configured to communicate with the sleeve or brace.

Embodiments of the invention further include a support and/or treatmentsystem, including an orthopedic footbed adapted to be worn by a patient.A footbed sensor is integrated with the orthopedic footbed, andconfigured to measure a load and/or weight thereon. A control deviceremote from the orthopedic footbed and connected to the footbed sensorover a network, and the control device is configured to measure andmodel stress in a foot, knee, and/or hip of the patient.

The footbed sensor can include an array of load cells in at least one ofa heel location or a forefoot location of the orthopedic footbed. Thearray of load cells can be a quint (5) array, such as including fourcorner load cells about a center load cell. A low power wirelesstransmitter can be disposed within the orthopedic footbed, and incommunication with the control device. The low power wirelesstransmitter can be configured to send readings to a connected smartphoneand the smartphone comprising an application that stores readingslocally and transmits the readings to a remote cloud server. A powersubsystem can also be integrated with the orthopedic footbed, includinga kinetic energy source configured to generate power from movement ofthe orthopedic footbed.

In embodiments of the invention, the orthopedic footbed comprises abrace or a sleeve configured to extend about a foot of the patient. Afurther sensor subsystem can be integrated with the orthopedic footbedor the brace or the sleeve, and in communication with the controldevice. Example sensor subsystems include a pulse sensor, a blood flowsensor, a blood pressure sensor, an oxygen sensor, a temperature sensor,an electric sensor, a moisture sensor, a biological/chemical sensor, arange of motion sensor, a compression/resistance sensor, acircumferential strain gauge, or combinations thereof. The sensorsubsystem can be/include an electric sensor configured to determinemuscular micro-electrical activity. The sensor subsystem can be/includea flexible ring integrated with the brace or sleeve and configured to bedisposed about the foot, and at least one sensor adapted to measureswelling in the foot within the ring.

An adjustment mechanism can be/include a compression subsystemintegrated with the brace or the sleeve and having variable tensioncontrollable by the control device via the control unit. The compressionsubsystem can include a rotating rod and a motor configured to rotatethe rotating rod to adjust a compression or tension in the brace or thesleeve. The compression or tension can be automatically monitored by thesensor subsystem and automatically adjustable by the control device.

The foot device can be used in concert with outer devices of thisinvention. The control device can communicates with the footbed sensorthrough a control unit of a second orthopedic device simultaneously wornon the patient. The second device can be a knee brace or sleeveincluding a support structure and an interior cavity configured toreceive a knee of the patient, such as described above.

In one embodiment of the invention, the system includes: a firstorthopedic device comprising a knee support brace adapted to be worn bya patient; a control unit including a processor integrated with thefirst orthopedic device; a telemedicine control device remote from thefirst orthopedic device and connected to the control unit over anetwork; an adjustment mechanism integrated with the first orthopedicdevice, wherein the control unit is in controlling combination with theadjustment mechanism, and the adjustment mechanism comprises acompression subsystem integrated with the first orthopedic device andhaving variable tension controllable by the telemedicine control devicevia the control unit, the compression subsystem comprises: a rotatingbar or rod and a motor configured to rotate the rotating bar or rod toadjust a compression or tension in the first orthopedic device, and aplurality of straps each connected at a first end to the rotating bar orrod and fixed at a second end to the brace or sleeve, wherein rotationof the rotating bar or rod tightens or loosens the plurality of strapsto adjust compression of the brace or sleeve about an internal cavity ofthe brace or sleeve; a sensor subsystem integrated with the firstorthopedic device and in communication with the control unit, whereinthe compression or tension is automatically monitored by the sensorsubsystem and automatically adjustable by the control unit, and whereinthe sensor subsystem comprises a first flexible ring integrated with thefirst orthopedic device, encircling the internal cavity of the brace orsleeve, and with at least one sensor adapted to measure swelling in abody part within the first flexible ring and the first orthopedicdevice; a second orthopedic device comprising an orthopedic footbedadapted to be worn by a patient; and a footbed sensor integrated withthe orthopedic footbed, and configured to measure a load and/or weightthereon, wherein the telemedicine control device is remote from thesecond orthopedic device and connected to the footbed sensor over thenetwork. The telemedicine control device is accessible by a remotelylocated telemedicine healthcare provider to receive metrics from thecontrol unit and the footbed sensor, and for control and adjustment ofthe adjustment mechanism and the first orthopedic device throughouttreatment of the patient by the telemedicine healthcare provider via thefirst orthopedic device.

The invention further includes a method of support or treatment usingthe orthopedic device described herein. The method includes one or moresteps of: providing the orthopedic device to a patient, gathering datavia sensors and the control unit of the device, automaticallycommunicating the data to the remote control device, communicatingoperation instructions back to the control unit, and automaticallyadjusting a tension and/or compression in the device using the controlunit and the adjusting mechanism. The method can include continual orperiodic monitoring and communication, and repeating the reporting andadjustment steps as needed. The invention further includes encodedinstructions for implementing the method steps, and appropriatelypartitioned and stored on recordable mediums of the control unit and/orthe remote control device.

An additional embodiment of the sleeve of this invention is formed as aninfant body suit. This suit in conjunction with the disclosed startlemechanism reduces the likelihood of suffering from SIDS.

To prevent SIDS, oxygen must steadily flow to the infant. As such, oncea controller determines that the infant lacks oxygen, it triggers thedisclosed startle mechanism(s) to startle and awaken the infant,typically resulting in the infant crying, and thus, forcing oxygen intothe infant's lungs.

The disclosed method, device, and system relies on a sleeve-based bodysuit and a mobile, foldable, and/or tent-like encasement comprising of,but not limited to motors, fans, pulleys, platforms, paddings, puncturedevices, heaters, coolers, and coverings. Although described via aseries of specific illustrations, one skilled in the art will realizethat many deviations of the described approaches are possible, andlikewise, they too are covered under this disclosure.

While aspects of the present disclosure can be described and claimed ina particular statutory class, such as the system statutory class, thisis for convenience only and one of skill in the art will understand thateach aspect of the present disclosure can be described and claimed inany statutory class. Unless otherwise expressly stated, it is in no wayintended that any method or aspect set forth herein be construed asrequiring that its steps be performed in a specific order. Accordingly,where a method claim does not specifically state in the claims ordescriptions that the steps are to be limited to a specific order, it isno way intended that an order be inferred, in any respect. This holdsfor any possible non-express basis for interpretation, including mattersof logic with respect to arrangement of steps or operational flow, plainmeaning derived from grammatical organization or punctuation, or thenumber or type of aspects described in the specification.

As used in the specification and the appended claims, the term“orthopedic” is not intended to be limited to referring to medical careby a physician, and generally refers to any support, improvement, ortreatment of one or more body parts, such as for medical treatmentand/or improved performance (e.g., every day or athletic performance)

As used in the specification and the appended claims, the singular forms“a,” “an” and “the” include plural referents unless the context clearlydictates otherwise. Thus, for example, reference to “a sleeve,” “acontroller,” or “a rod” includes mixtures of two or more such functionalsleeves, controllers, or rods, and the like.

Ranges can be expressed herein as from “about” one particular value,and/or to “about” another particular value. When such a range isexpressed, a further aspect includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms a further aspect. It willbe further understood that the endpoints of each of the ranges aresignificant both in relation to the other endpoint, and independently ofthe other endpoint. It is also understood that there are a number ofvalues disclosed herein, and that each value is also herein disclosed as“about” that particular value in addition to the value itself. Forexample, if the value “10” is disclosed, then “about 10” is alsodisclosed. It is also understood that each unit between two particularunits are also disclosed. For example, if 10 and 15 are disclosed, then11, 12, 13, and 14 are also disclosed.

As used herein, the terms “optional” or “optionally” means that thesubsequently described event or circumstance can or cannot occur, andthat the description includes instances where said event or circumstanceoccurs and instances where it does not.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying figures, which are incorporated in and constitute apart of this specification, illustrate several aspects and together withthe description serve to explain the principles of the presentdisclosure.

FIG. 1 illustrates a brace or sleeve according to one embodiment of thisinvention.

FIG. 2 shows a representative control unit according to one embodimentof this invention.

FIG. 3 shows a representative swelling detection ring according to oneembodiment of this invention.

FIG. 4 shows a representative resistance rod according to one embodimentof this invention.

FIG. 5 shows a representative adjustment mechanism according to oneembodiment of this invention.

FIG. 6 shows a representative network controller mechanism according toone embodiment of this invention.

FIG. 7 illustrates a brace or sleeve according to another embodiment ofthis invention.

FIG. 8 illustrates an orthopedic footwear insert according to oneembodiment of this invention.

FIG. 9 shows a representative footwear insert configuration according toone embodiment of this invention.

FIG. 10 shows a load sensor cell according to one embodiment of thisinvention.

FIGS. 11-17 each show a representative sensor array according toembodiments of this invention.

FIG. 18 shows a load sensor according to one embodiment of thisinvention.

FIG. 19 shows a representative footwear brace, sleeve, and/or insertconfiguration according to one embodiment of this invention.

FIG. 20 shows a computing system according to one embodiment of thisinvention.

FIGS. 21 and 22 each show a mobile device user interface according toone embodiment of this invention.

FIG. 23 illustrates an infant body suit with the left arm attached tothe center of the body.

FIG. 24 illustrates an infant body suit with the right arm attached overand to the left arm sleeve.

FIG. 25 illustrates a SIDS prevention encasement, according to oneembodiment of this invention.

FIG. 26 shows the encasement on a stand according to one embodiment ofthe invention.

FIG. 27 shows an encasement resting on a bed.

FIG. 28 illustrates components of an encasement, according to oneembodiment of this invention.

FIGS. 29 and 30 illustrate a pulley system for an encasement, accordingto one embodiment of this invention.

FIG. 31 shows a power and drive mechanism for an encasement, accordingto one embodiment of this invention.

FIG. 32 shows an end of an encasement, according to one embodiment ofthis invention.

FIGS. 33-36 each show a shoe startle mechanism, according to oneembodiment of this invention.

Additional advantages of the disclosure will be set forth in part in thedescription which follows, and in part will be obvious from thedescription, or can be learned by practice of the disclosure. Theadvantages of the disclosure will be realized and attained by means ofthe elements and combinations particularly pointed out in the appendedclaims. It is to be understood that both the foregoing generaldescription and the following detailed description are exemplary andexplanatory only and are not restrictive of the disclosure, as claimed.

DETAILED DESCRIPTION OF THE DRAWINGS

The invention provides a support or treatment system that includes asupport or treatment device in combination with a remote monitoringand/or controlling device. The support or treatment device can be anysuitable orthopedic device, such as a brace or sleeve for one or morebody parts. Exemplary sleeves or braces include, without limitation,prophylactic sleeves or braces, rehabilitative sleeves or braces,functional sleeves or braces, unloader/offloader sleeves or braces,splints, boots, supports, and immobilizers, with rigid exoskeletonand/or flexible support structures, for any one or more body parts, suchas, without limitation, ankles, legs, knees, hips, shoulders, necks,torsos, backs, hands, wrists, fingers, or elbows. The remote controldevice can be a computer (such as a workstation, personal computer,tablet, etc.), a mobile device (such as a conventional or an intelligentcell phone) or any other controller communicating over a network. Alocal control device can additionally or alternatively can be configuredas part of the device.

For purposes of illustration, FIG. 1 shows an exemplary orthopedicdevice according to one embodiment of this invention. The device 100includes a support structure embodied as a sleeve 110, such as for aknee or elbow, having an internal cavity 112 accessible at either end byopenings 114. The sleeve 110 is formed of any suitable material, such asa compression material or fabric to form a compressible sleeve for usewith an injury at or near a knee or elbow joint of a subject. The sleeve110 can be compressed according to embodiments of this invention in amanner that decreases the circumference of the sleeve and internalcavity, thereby providing compression to the surface of, for example,the thigh, knee, and/or calf.

In embodiments of this invention, the sleeve 110 includes a sensorsubsystem of various sensing devices that interact via control deviceswith a software interface that is accessible to the subject and/or aremotely located healthcare provider such as a physician, physician'sassistant, nurse practitioner, physical therapist, trainer, and thelike. In some embodiments, the data from one or more sensing devices canbe provided to the subject via a software interface hosted on a smartdevice such as a smart phone device wherein the data are transmitted tothe smart device via a protocol such as Bluetooth or Wi-Fi standardprotocols. The sensing devices incorporated into the sleeve can beselected based on the desired parameters to be followed for the specificapplication, e.g., sensors (including microsensor or nanosensor devices)can be incorporated that determine temperature, moisture, and specificmaterials to permit collection of data relevant to whether the subjecthas active inflammation, infection, or healing occurring at or near aninjury or wound site encompassed by the sleeve 110. The data can also betransmitted using internet protocols via Wi-Fi or telephony protocols toa remotely located user such as a healthcare provider. It is likewisewithin the scope of this invention that the transmitted data areencrypted.

The orthopedic device of this invention desirably includes an adjustmentmechanism integrated with the orthopedic device. The adjustmentmechanism can include one or more adjustment devices or elements such asstraps, rods, bars, and/or braces with variable tension, wherein thetension can be controlled by the user and/or a healthcare provider asrequired for a treatment protocol and/or based on data provided by oneor more sensors on the orthopedic device. It is likewise within thescope of this invention that the tension is continuously monitored andcomputed on the orthopedic device using a resident software subsystemand is adjusted automatically in response data collected by the sensorsubsystem.

Referring to FIG. 1, the sleeve 110 can be tensioned using an adjustmentmechanism in combination with a sensor subsystem. In FIG. 1, resistancerod sensors 135 are placed as appropriate for the specific use of theorthopedic treatment system such that the one or more resistance sensors135 determine and control a resistance rod 134 of the adjustmentmechanism. In embodiments of this invention, the orthopedic treatmentdevice, such as sleeve 110, can make use of a combination of resistancerod sensors and resistance rods made of composite materials to providevariable weight tension/resistance to the subject using the orthopedictreatment device. In embodiments of this invention, the torsion ofcomposite fibers in a resistance rod can be increased, e.g., in a middlethird of a resistance rod, via a micromotor or nanomotor device toprovide stiffening of the resistance rods, and thereby, increasingtension for therapeutic benefit such as prehab and rehab for patientsundergoing joint replacement surgery. An additional benefit to thesepatients is the ability to reduce the risk of hyperextension of theknee.

In various aspects, the disclosed orthopedic treatment system can beused by a patient or subject having various joint injuries, and providesstructural support for the joint, such as during bending and/or flexing,using controlled (via the control device) resistance rods thatfacilitate patient rehabilitation. The sleeve includes controlledresistance rods that allows the user to gain strength in the joint beingtreated as well as rehabilitate the supporting musculoskeletalstructures around the affected joint.

The brace or sleeve of this invention desirably tensions and releasestension components to provide the patient with highly controlledcompression which is precisely controlled by a remote control device160. Accordingly, healthcare providers can monitor the compression andset thresholds for each patient or groups of patients based on readingsand/or other considerations as determined by their healthcare provider.

Accordingly, in various embodiments of this invention, healthcareproviders can control, namely monitor and adjust the sleeve via eitherdirect or indirect communication with the sleeve using a communicationport in the controlling device. Therefore, providers are able tointeract with the individual wearing the sleeve (namely, the patient)regardless of their geographic location. The healthcare provider canguide the patient using any known in the art methods. In variousembodiments of this invention, such methods can include guidance viapatient based metrics received via a telemedicine interface, e.g., aNetMetCare interface as described herein below. Communications can beaccomplished via any network medium, namely, for example, over theInternet or cellular service.

The orthopedic treatment system of embodiments of this invention is usedfor rehabilitation and general treatment of injuries, such as to theknee, hip, shoulder, ankle, spine, wrist, or elbow. The orthopedictreatment system of this invention makes use of a unique set of sensors,power generation, power storage, strain gauges, and motors, and makesuse of micro- and nano-technologies. The disclosed brace or sleevecomponent of the orthopedic treatment system is designed to beself-powered, waterproof, washable, and come in numerous sizes tosupport children, adults, and the elderly, thin, heavy set, to obese.

The disclosed orthopedic treatment system of embodiments of thisinvention includes an intelligent controller. With such a controller,the direct monitoring and alerting for specified conditions issupported. That is, the healthcare provider, e.g., a trainedprofessional, friend, family member, acquaintance, or designee or even acomputer program supporting artificial intelligence, can program theintelligent controller to detect any deviation from a desired condition.Such condition(s) can be, for example, without limitation, if the braceor sleeve is insufficiently exercised, the patient wearing the brace isperspiring or is simply too hot, or any other monitored conditioned. Ifa condition is detected, an alert can be triggered. As the communicationbetween the healthcare provider and the patient wearing the sleeve isbidirectional, this alert can be immediately sent to any monitoringindividual or device, and a responsive action, if appropriate, can beinitiated.

Although the alert notification is primarily for the healthcareprovider, it can likewise be of interest to the patient as in a form ofa feedback loop. That is, such an alert can serve as a reminder to thepatient to, for example, exercise as guidance for proper use, asreinforcement for moral support, positive feedback on meeting treatmentgoals, and the like, and other feedback as can be determined to beneeded by a healthcare provider, subject, and/or manufacturer of theorthopedic treatment system.

Alerts according to embodiments of this invention include sending analert to the user and their healthcare provider in the event the user isexperiencing unexpected results from, for example, surgery.Additionally, the system can provide range of motion alerts to the userand healthcare provider alerting them to increase or reduce theirexercise accordingly.

In embodiments of this invention, conditions can be detected via builtin sensors in the brace or sleeve. In a further aspect, an alert can betriggered by the presence of moisture, such as from a discharge ordrainage from a wound or surgical incision. For example, the sleeve canbe configured with at least one moisture sensor. Such sensors cansupport surgery rehabilitation. Namely, the sensors monitor for anydrainage from the incision and can alert both patient and healthcareprovider as appropriate.

The brace or sleeve may likewise be configured with at least onebiological or chemical sensor. For example, these sensors can be used toanalyze any drainage from an incision. Such analysis can providefeedback to regarding biological or physiological status to themonitoring healthcare provider on the biological makeup of the drainage.Specifically, this feedback can significantly assist in surgeryrehabilitation.

Using sensors, the brace or sleeve may likewise provide localized bodytemperature of the skin surface at or near a joint of a subject, e.g.,the knee, and have appropriate upper and lower thresholds set.Alternatively, the sensor can provide data to assess time dependenttrends or alterations in temperature. Additionally, through monitoringthe trajectory of the temperature over time, the system provides earlyindications of a potential medical event. Note that it is within thespirit of this invention that not all versions of the sleeve arenecessarily configured the same or with all specified components.

As discussed above, the readings from the sensors are desirablycommunicated to the healthcare provider. Thus, by using a virtual modelof the portion of the body of the patient being treated along with thesensor readings obtained, an accurate representation of the patient'scurrent physical condition can be provided to the healthcare provider.By introducing a potential treatment option to the model, the healthcareprovider can simulate a potential reaction of the patient to theproposed option without actually subjugating the patient to thatparticular treatment option. Thus, multiple treatment scenarios can beanalyzed with the best scenario being selected prior to initiating anactual treatment option for the patient. In doing such, the patientbenefits from the best option without potentially suffering anon-optimal decision.

It is likewise within the scope of this invention to support andvisualize longitudinal studies of the patient treatment and/or recoveryprocess. More so, a comparison of other patients exposed to similartreatments can be provided to the healthcare provider. The mining ofpast outcomes can be incorporated into the treatment guidelines for thepatient and their healthcare provider. Any of the many visualizationapproaches, and machine learning, data mining and/or inferenceapproaches known in the art can be used to support the disclosedvisualization and mining.

Also, it is likewise within the scope of this invention to configure acontroller to control multiple simultaneous sleeves for one or morepatients. In such manner, for example, a patient can wear multiplesleeves (on differing body parts) and the healthcare provider can beprovided with reading from multiple sleeves forming a more completeunderstanding of the patient condition.

The system and device of this invention are suitable for both pre- andpost-operative care as well for routine physical therapy, as well asmany other uses such as physical training, sport performanceimprovement, prophylactic treatment, and the like. In FIG. 1, the sleeveis illustrated, without loss of generality, as a supportive gear for ahuman knee or elbow. However, in various aspects, using the same design,the disclosed sleeve, with appropriate size and shape modifications, islikewise can be used for treatment of a human hip, shoulder, spine,wrist, ankle, etc. The braces or sleeves of this invention make use of,depending on individual need, a unique set of sensors, stimulators,power generation, power storage, strain gauges, and motors. The devicesdesirably make use of micro and nano technologies, and can be designedto be self-powered, waterproof, washable, and/or available in multiplesizes. Multiple sizes may be needed to accommodate the varying agegroups and body sizes of the target population, namely, youth, adults,and elderly, thin, heavy-set, and obese.

The overall design of the brace or sleeve includes one or more sensingdevices, stimulators, rods, motors, power sources such as batteries,capacitors, or others known in the art, networks, and networkinterfaces. Exemplary sensing devices are or include sensors designed todetect and measure electrical, moisture, biological, temperature,pressure, sound inputs, etc. Stimulators include, without limitation,those designed to provide electrical, pressure, or puncture stimulation.The rods can be flexible and/or stiff and can be made from a diversityof materials such as metals, coils, wires, plastics, and fabrics. Themotors can be of various types and sizes, their exact compositiondepending on their functionality requirements and availability as knownin the state-of-the-art. The batteries can be potentially rechargeableand small, as known in the art, and can be configured to indicate lowpower capacity. Other, potentially rechargeable, power sources known inthe art are likewise possible. Gears, gyroscopes, and coils, as known inthe art, can likewise be used to generate and store energy and serve asa power source.

The body of the brace sleeve can include a mesh network that supportsthe components and communication and control of the configuredcomponents as needed. A network interface that receives instructions andtransmits readings can be likewise included. Alternative device supportstructures can include a rigid support structure with adjustable tensionjoints and/or straps, such as shown in FIG. 7. Combinations of rigid andflexible materials are also possible, depending on need.

Referring again to FIG. 1, sleeve 110 is suitable as a knee joint braceor sleeve for a subject. It is understood that a subject can be a human.Alternatively, a subject can be a mammal, e.g., a horse or companionanimal. In referring to FIG. 1, “orthopedic treatment device”, “sleeve”and “brace” can be used interchangeably herein. As used herein, “brace”and “sleeve” can be used to refer to a same type of device, particularlyas some devices have both brace and sleeve elements, or can refer todifferent types of devices, such as braces that incorporate hard shellcomponents and, likely straps, versus sleeves formed of, for example, afabric tube-like structure.

In FIG. 1, sleeve 110 comprises a control unit 140 to receive data from,operate, or otherwise control components of the device 100. Inembodiments of this invention, the control unit 140 includes or isconnected to a power source, a central processing unit with acorresponding operating system, a network controller, sensors, and astatus panel. The control unit 140, and any related but separatecomponent, is connected to the sleeve 110, such as fixed to the outersurface of the sleeve by any suitable connection and connectors.

FIG. 2 generally and schematically illustrates a control unit 140according to one embodiment of this invention. The control unit 140includes a power source 201. The power source can be a self-generatingsource of power, such as via device motion using the illustratedgyroscopic generator module, which provides energy to an associatedenergy storage unit 202. Similarly, the power source 201 can be anyother suitable energy source, e.g., a rechargeable battery unit. Theplacement of the power source for powering the operation of the devicediffers depending on what part of the body the device supports anddepends on, but is not limited to, the motion or mobility of the jointand the characteristics and comfort of the wearer. In an exemplaryembodiment for the knee, the power subsystem and power source 201 isplaced in the arc of the cavity behind the knee, which provides alocation that produces the energy to power the device through theflexing of the joint while the user goes about daily activities. Thisplacement also provides a high level of comfort to the user as the powersubsystem is ‘hidden’ out of the way behind the knee. In embodiments ofthis invention, the criteria for placement of the power subsystem on thewearer include one or more of, without limitation, the part of the bodyunder treatment, the size (height and weight), age, gender, and comfortof the user, and the location that supports self-power generation ifsuch feature is supported. That is, it is within the scope of thisinvention that either individually or in combination thereofself-generating and provided power, for example via a battery, providesthe necessary power to fully operate the systems of the orthopedicdevice of this invention.

A central processing unit and a recordable medium with encodedinstructions for a corresponding operating system 203 are likewiseincluded and is powered by energy from the energy storage unit 202. Inembodiments of this invention, any low power central processing unit(CPU), driven by an operating system (OS) known in the art can be used,e.g., a Raspberry Pi-based CPU. The CPU and OS control the globalfunctioning of the sleeve 110, executing instructions and issuingcommands as programmed. It is within the scope of the invention that theCPU and OS combination will include data encryption and decryptionsoftware, enabling the transmission of encrypted data.

The CPU 203 is in communication with a network controller 204 thatprovides transfer of data from readings and commands throughout thesleeve 110 to a remote control device, such as a smartphone or othercontrolling device. As discussed above, the remote control device can bea computer (such as, workstation, personal computer, tablet, etc.), amobile device (such as, a conventional or an intelligent cell phone) orany other controller. In a further aspect, the remote controlling devicecan be configured as part of the sleeve or brace, or alternatively,configured to communicate with the sleeve or brace. Any low powernetwork can be used for communicating with components on the sleeve.Communication with the remote device can be supported via any networktechnology or protocol known in the art, e.g., Bluetooth, wireless,Internet, and cellular, such as over a wireless signal accessible to thesleeve control unit 140 through a wireless router 150 shown in FIG. 1.

Further, the control unit 140 embodied in FIG. 2 likewise is connectedto sensors of a sensor subsystem 205 integrated with the sleeve. Thearray of sensors measure, for example, temperature, moisture, electricalpulses, sound, and/or blood flow. Green light emitting diodes (LED) 206visually monitor blood flow. The sensors monitor the blood flow in themain artery and vein of the recovering body part. Improper flow of bloodfrom the heart (in the monitored artery) or from an extremity to theheart (in the monitored vein) can indicate poor circulation. Whencoupled with pulse readings obtained by the audio sensor 207, the bloodpressure and temperature obtained by the coupler 208, poor circulationcan be for example, an indicator of an arrhythmic condition. Aninference engine running either on the local CPU 203 or on the remotedevice can suggest appropriate actions. Any suitable sensors areavailable for the sensor subsystem, including, without limitation, pulsesensors, blood flow sensors, blood pressure sensors, oxygen sensors,temperature sensors, electric sensors, moisture sensors, biologicaland/or chemical sensors, range of motion sensors, compression and/orresistance sensors, circumferential strain gauges, or combinationsthereof.

The sensor subsystem of FIG. 1 includes two flexible rings 122, one ator approximate each of two ends of the sleeve 110. The rings 122 can beoriented with one toward and about the thigh and one toward and aboutthe calf, as shown in FIG. 1. These rings 122, shown in greater detailin FIG. 3, can be sensors used to determine the level of swellingsurrounding the recovering body part, such as the knee. As shown in FIG.3, a non-limiting four sensors 302 measure the pull (hencecircumference) of the attached cable 301. By measuring thecircumference, the precise level of swelling is noted. Although foursensors 302 are shown, it is within the scope of this disclosure to havea greater or smaller number of sensors. Any suitable sensor, such as astrain gauge, can be used to form the rings 122.

In an aspect, the sleeve 110 of FIG. 1 can contain an assortment ofsensor(s) and stimulator(s) 123 in multiple positions. In variousaspects, these sensor(s) can measure a diversity of inputs such asmoisture, electric current, and sound. The data signal or informationderived from such inputs, like with other components in the orthopedictreatment system, can be sent via a network to the CPU for furtherprocessing. The stimulators send pulses to simulate the body part undercare. Stimulation targets to invoke body responses to be measured,provide treatment, or to serve as a form of reminder.

FIG. 4 shows an exemplary resistance rod 134 integrated with the sleeve,such as on opposing sides of, or at other predetermined placementsabout, the interior cavity, and designed to flex in the direction of,and along with, the enclosed joint. The rod 134 of FIG. 4 includes tworigid sections 401, one at each end, and a center section 402 that isflexible. The center section 402 can be tightened or loosened so as tostress or release the tension of the rod 134. In embodiments of thisinvention, a nano motor 403 is attached to each rigid section of the rodas shown. The motors can rotate in counter directions to each other,i.e., one clockwise the other counter-clockwise. For example, rotatingthe motors in one pair of opposing directions can tighten the rod; andreversing the rotation of both motors can loosen the rod. It is withinthe scope of this invention that either motor rotate in either directionto tighter or loosen the rod as long as they rotate counter to eachother. In embodiments of this invention, the middle section is formed ofunidirectional stranding of composite fibers 405 to provide theflexibility and torsional tightening. Exemplary composite fibers includemonofilament carbon fibers that collectively tighten with or againsteach other when twisted, somewhat analogous to the tightening of abraided rope when twisted.

As shown in FIG. 1 alongside one or more of the rods 134 an array ofsensors 124 can likewise be included on or in the sleeve 110. This array124, like the other sensors, records readings and sends them to thecontrol unit 140 for further processing. In particular, this array ofsensors 124 measures the range of motion exhibited by the body partunder treatment.

In some embodiments of this invention, such as shown in FIG. 1, abiological sensor 126 is included in or on sleeve 110. The sensor 126can perform a biological or chemical analysis of the seepage surroundingan incision or wound. For example, the sensor itself conducts a chemicalanalysis of a substrate present in the seepage from an incision orwound. Any such chemical analysis known in the art can be used. It islikewise within the scope of this disclosure that the analysis isconducted by multiple components. More so, it is within the scope ofthis disclosure that the biological sensor 126 is placed in multipleplaces within the sleeve 110. Results of the biological analysis can becommunication to the control unit 140.

The adjustment mechanism of this invention can additionally oralternatively include a compression subsystem that provides a tighteningand loosening functionality through all or one or more sections of theorthopedic device. FIG. 1 shows a compression subsystem with compressionstructures 127 on each end of the sleeve 110. FIG. 5 shows an exemplarycompression structure 127 according to embodiments of this invention.The compression structure 127 includes, along a section of the sleeve110, a pair of spaced apart bars 501 that can be secured to the sleeveby threads, flaps, or other suitable means. Straps 505 are attached toand between one of the respective bars 501 and a central rotating bar503 controlled by motors 502 can be used to tighten and loosen thecompression structure, and thus the sleeve. The motors 502 rotate in asame direction, and the straps 505 either tighten the sleeve 110 bywrapping themselves around the rotating bar 503 and pulling the bars501, or loosen the sleeve 110 by unwrapping themselves from the rotatingbar 503. Thus, pressure can be exerted on the healing body part, asneeded and controlled by the remote control unit. Various andalternative sizes, shapes, and configuration are available for thecompression structures, bar, straps, and rods, depending on need. Forexample, only one bar may be needed, or the straps can be directlyattached or integrated to the sleeve without the bars.

FIG. 6 illustrates an exemplary network controller unit 204 comprisingvarious subunits such as an operating system subunit 601, a networkassembly subunit 602, a radio/protocol subunit 603, and/or one or morenetwork communication subunit 604. The network controller 204 can belocated within control unit 140 or an assembly thereof. In embodimentsof this invention, the control unit 140 includes a computing unitrunning an operating system subunit 601 to support the networkcommunication flow controlled by the network controller 204. Networkconfiguration details can be maintained in the network assembly subunit602. Protocol specifications can be maintained on a radio/protocolsubunit 603 for one or more network communication subunit 604, such aswireless, mesh, Bluetooth, and cellular networks. Some of the networkcommunication subunits can communicate with one or more of thecomponents on the sleeve, e.g., a sensor or motor device; whereas othernetwork communication subunits can communicate with a remote device. Itis within the scope of this invention to support additional or alternatenetwork types as known in the art. It is likewise within the scope ofthis invention to integrate both logically and/or physically thefunctionalities of the above components into fewer components or topartition them across a greater number of components.

FIG. 7 shows an exemplary orthopedic device 700 according to oneembodiment of this invention. The device 700 includes a supportstructure with a jointed rigid knee brace 710. Straps 720 and comfortsleeves 730 form an internal cavity 712. A joint pivot 724 can beintegrated with a resistance rod 726, such as discussed above for FIG.4. One or more of the strap 720 can be tightened according toembodiments of this invention, such as with a compression mechanism 730similar to shown in FIG. 5, in a manner that decreases the circumferenceof the straps 720 and internal cavity 712, thereby providing increasedsupport and/or compression to the surface of, for example, the thighand/or calf

In embodiments of this invention, all readings collected can be storedin a database. Any database management system known in the art can beused. The sleeve periodically (logically continuously) records andtransmits readings; thus, the database can store these readings creatingan individual longitudinal history. By utilizing any alerting ortriggering monitoring approach known in the art, conditions ofsignificant interest for patient care can quickly be detected, and thesupervising healthcare professional can be alerted. More so, by usingany trend detection approach known in the art, even minor fluctuationsor conventional readings that normally would go undetected can be notedif they are part of a trend of interest. For example, a continuousslight increase in temperature might indicate infection if this readingis sustained for a prolonged period of time.

Patient treatment history can be visualized. The treating healthcareprofessional can request varying charting and presentation visualizationdisplays of the stored history. Additionally, using patient treatmentmodels, models potentially using input parameters stored in the databasethat can be patient specific, a variety of potential treatment optionscan be considered. For example, contraction of the sleeve might beconsidered, and the model might suggest possible reactions of thepatient should these contractions be activated. Thus, various treatmentoptions can be attempted, and the best option selected withoutsubjecting the patient to unnecessary and potentially unhealthyapproaches.

The following exemplary components can be used to implement anon-limiting aspect of the disclosed invention. It is within the scopeof this invention, however, to use any known in the art technologies tosupport the components to implement the disclosed sleeve. The componentscan comprise a power source, a sensor, a communication subsystem, acomputation subsystem, e.g., a CPU, and a compression subsystem. It islikewise within the scope of this disclosure to integrate both logicallyand/or physically the functionalities of the above components into fewercomponents or to partition them across a greater number of components.

In various embodiments of this invention, exemplary components include:power subsystem; sensor subsystem comprising six primary sensors(temperature sensor, electric sensors, moisture, biological, andchemical sensors, range of motion sensors, resistance rod sensors, andcircumference measurement sensors); communication subsystem; compressionsubsystem; motor assembly; software; and telemedicine support.

1. POWER SUBSYSTEM

In embodiments of this invention, the orthopedic treatment deviceincludes a power subsystem. In some embodiments, such as illustrated inFIG. 2, the power subsystem includes a generator based on gyroscopic andinertial components 201, that generates voltage and amperage (VA) viainternal motion and the energy so generated is stored in a kineticenergy storage unit (KESU) 202. In a further aspect, the power subsystemcan comprise a micro-wiring harness for distributing power to thevarious devices in the sleeves.

2. SENSOR SUBSYSTEM

In some embodiments, the sensor subsystem can include one or more of thefollowing primary subcomponents: temperature sensor; electric sensors;moisture, biological, and chemical sensors; range of motion sensors;resistance rod sensors; and circumference measurement sensor. Theprimary subcomponents can be microscale or nanoscale sensor devices. Thesensor subsystem can further include other subcomponents as determinedby the needs or requirements of a healthcare provider and/or subject.

a. ELECTRIC SENSOR

The sensor subsystem can include one or more electric sensor(s). Theelectric sensor(s) can be located within or on one or more pads locatedwithin or on the orthopedic treatment device. As shown in FIG. 1,without limitation, a plurality of sensors 123, such as bioelectricalsensors, can also be located within or on two pads located within or onthe sleeve 110. The electric sensors can be placed on the orthopedictreatment device such that electrical impulses in, for example, thethigh and calf of the subject can be determined.

The electric sensor(s) desirably determine(s) muscular micro-electricalactivity. The micro-electrical activity data can be used to determinerecovery status of one or more muscles, i.e., a method of measuring thehealth status of a muscle. In some embodiments of this invention, themicro-electrical activity data can be used to determine parametersuseful for a prehabilitation protocol. For example, in a subjectundergoing prehabilitation therapy, the micro-electrical activity withinthe muscle can be used to assess the level of stress placed upon one ormore muscle, and thus, can be used to determine the exercise level thata subject is exerting. It is understood that prehabilitation, oralternatively referred to in the art as “pre-hab,” refers to a form ofstrength training, aims to prevent injuries before the actualoccurrence. Since rotator cuff and elbow injuries, among other things,are common among athletes in a wide range of sports, training themuscles surrounding these vulnerable joints can prevent injuriessustained from repeated wear and exertion.

b. RANGE OF MOTION SENSOR(S)

The sensor subsystem can include one or more range of motion sensors. Asseen in FIG. 1, the range of motion sensors 124 can be placed asappropriate for the specific use of the orthopedic treatment system suchthat a range of motion can be determined. The range of motion sensorscan use various techniques known in the art to measure the movement ofthe joint to determine the range of motion in the joint.

In some embodiments the orthopedic treatment system comprises at leasttwo range of motion sensors located such that the range of motionspecific to the area of the body being treated can be determined, e.g.,the range of motion that a subject can provide between the upper andlower arm wherein the orthopedic treatment device is designed fortreatment of an elbow, or alternatively, the range of motion that asubject can provide between the upper and lower leg wherein theorthopedic treatment device is designed for treatment of a knee. Forexample, in an orthopedic treatment system for the knee, the range ofmotion sensor can measure the range of motion through the arc in which aknee travels. In one embodiment, the orthopedic treatment system isdesigned for use with a knee injury and comprises two range of motionsensors.

As another example, for an orthopedic treatment system for the hip, therange of motion sensor can measure both the arc of motion and rotationat the hip. In a still further non-limiting example, an orthopedictreatment system for the shoulder, the range of motion sensor canmeasure both rotation at or around the shoulder and the forward back arcmotion. In various embodiments, the joint range of motion that ismeasured is dependent upon the joint or body region for which theorthopedic treatment system is utilized, and sensor placement and numbercan be determined by the skilled artisan to provide more or less planethrough which they measure the joints action.

c. MOISTURE, BIOLOGICAL, AND CHEMICAL SENSORS

The sensor subsystem comprises moisture, biological, and/or chemicalsensors. The moisture, biological, and/or chemical sensors can be placedon the device as appropriate for the specific use of the orthopedictreatment system. For example, as shown in FIG. 1, the orthopedictreatment system is designed for use with a knee injury and themoisture, biological, and chemical sensors 126 are placed at or near aknee opening in the middle front of the sleeve 110 to allow thesesensors 126 to measure the moisture, biological material and/or chemicalmaterial being emitted at or near the site of placement. In thisexample, the moisture, biological, and chemical sensors 126 can detectpotential infection or seepage from a wound.

d. RESISTANCE ROD SENSOR(S)

The sensor subsystem comprises one or more resistance rod sensor(s)placed as appropriate to determine and control a resistance rod, such asrod 134 in FIG. 1. In embodiments of this invention, the orthopedictreatment device can make use of a combination of resistance rod sensorsand resistance rods made of composite materials to provide variableweight resistance to the subject using the orthopedic treatment device.The torsion of unidirectional stranding of composite fibers 405 in aresistance rod can be increased, e.g., in the middle third 402 ofresistance rod 134, via a micromotor or nanomotor device 403 to providestiffening of the resistance rods and thereby increasing resistance. Inembodiments of this invention the orthopedic treatment device caninclude two resistance rods wherein each rod can be controlledseparately. In another embodiment, the orthopedic treatment device caninclude a plurality of resistance rods distributed as appropriate aroundthe central axis of the inner cavity and joint, with each resistance rodsubject to independent control. The number and distribution of theresistance rods around a joint axis can be determined by a healthcareprovider as appropriate to the joint, type of injury, and rehabilitationalgorithm.

e. TEMPERATURE SENSOR(S)

The sensor subsystem can include a temperature sensor, such as locatedon the back of the orthopedic treatment device. In a further aspect, thetemperature sensor, such as a thermocouple sensor 208, is placed suchthat it senses the subject's body temperature behind the knee throughdirect contact with the skin.

f. CIRCUMFERENCE MEASUREMENT SENSOR(S)

The orthopedic treatment device comprises one or more circumferencemeasurement sensors 302, such as including at least one multi-sectionalstrain gauges that provides circumference measurements relative to thecentral axis of the joint or area of the body for which the orthopedictreatment device is being used to treat. In embodiments of thisinvention, the measurements can be calculated in four parts, which helpdetermine swelling in the region and the “shape” of the swelling. Shapedistortions describe mathematically how the swelling is manifested, inother words in which region of the extremity the swelling is occurring.

3. COMMUNICATION SUBSYSTEM

In embodiments of this invention, the orthopedic treatment deviceincludes a communication subsystem. The specific communication protocolor modality used can be any appropriate to the desired end use, takinginto account the preferred communication protocol or modality used bythe healthcare provider and/or subject using the orthopedic treatmentdevice that allows for directional communication of data and instructionbetween the orthopedic treatment device and an external user, e.g., ahealthcare provider and/or a subject using the device. For example, thecommunication subsystem can comprise one or more of the followingcommunication platforms MESH, Bluetooth, 3G, 4G, 4G LTE, 4G LTE+, 10MB,100MB, 1GB and higher wireless and future networking protocols. In afurther aspect, the communication subsystem can comprise TCP/IP, ZIGBEE3.0 and above; Z-Wave standards or any future communications protocolssuitable to the operation of the device. Similarly, the datacommunicated can be encrypted.

4. COMPRESSION SUBSYSTEM

In embodiments of this invention, the orthopedic treatment deviceincludes a compression subsystem. For example, as shown in FIGS. 1 and5, the compression subsystem can include three core components: a wovencompression support structure matrix; a flexible worm drive assembly;and a motor assembly. The woven compression matrix can comprise a seriesof interleaved fabric panels or straps 505 that can be pulled togetheror apart to increase or decrease pressure on a joint being treated. Theflexible worm drive assembly 503 allows the device to adjust thecompression of the orthopedic treatment device, i.e., as the worm movesthrough one full rotation it either releases or tightens the wovencompression matrix.

5. SOFTWARE SUBSYSTEM

In embodiments of this invention, the orthopedic treatment devicecomprises a software subsystem supporting bidirectional communicationwith various computing device platforms. In a further aspect, thesoftware subsystem comprises a software system residing on theorthopedic treatment device that communicates data obtained from sensorson or within the orthopedic treatment device to a software systemresiding on a remote controlling device such as a mobile deviceplatform, a tablet device platform, a laptop computing device platform,a desktop computing device platform, a cloud computing platform, a webappliance computing platform, and the like, or a combination of suchcomputing platforms. In a still further embodiment, the softwaresubsystem comprises a software system residing on the orthopedictreatment device that receives instructions from a software systemresiding on a remote control device such as a mobile device platform, atablet device platform, a laptop computing device platform, a desktopcomputing device platform, a cloud computing platform, a web appliancecomputing platform, and the like, or a combination of such computingplatforms.

In a further embodiment of this invention, the orthopedic treatmentdevice includes a software subsystem supporting bidirectionalcommunication to external mobile device platforms such as Apple iOS®,Google Android®, and Microsoft Windows®. Again, the data communicatedcan be, and desirably is, encrypted.

In a further embodiment of this invention, the software subsystemcomprises encoded software instructions on a recordable medium of theorthopedic treatment device that communicates data from sensors such asskin temperature, range of motion, and electrical impulses. The encodedsoftware instructions on a recordable medium of the remote controldevice, such as described herein above, can be designed such that skintemperature at the site of the device can be displayed in degreescentigrade or Fahrenheit; electrical impulses from the muscles can berepresented in a scale of 1-100, providing an indication muscle tissuehealth; and/or range of motion displayed in degrees on a scale of 0-360.

In a further embodiment of this invention, the software of the remotecontrol device, such as described herein above, can be designed suchthat user inputs can be provided to control the orthopedic treatmentdevice. For example, the software can be designed to provide a userinterface to control the compression level applied to the joint beingtreated by the device; and/or increase or decrease the tension on theresistance rods.

In a further embodiment of this invention, the injury being treated bythe orthopedic treatment device may involve specific types of swellingthat need to be monitored via the software subsystem. For example, theswelling could be more acute on the front of the thigh and less so onthe sides of the thigh and limited on the back of the thigh, thisinformation can be mapped and allow the associated software to representthe shape of the swelling via adaptive of virtual reality software anddisplay devices such as head gear and projection platforms and inmultidimensional representations on mobile platforms, computers andsmart devices such as TV sets.

6. TELEMEDICINE SUBSYSTEM

In embodiments of this invention, the orthopedic treatment deviceincludes a telemedicine subsystem. For example, the orthopedic treatmentdevice and software subsystem can further include communicationprotocols to provide network enabled care by providing healthcareproviders with access to the metrics being generated by the sensorsub-systems. These metrics include user-defined validations of high andlow thresholds. The software provides for general thresholds that can bemodified by the healthcare provider, where they deem closer monitoringof their patient is indicated. In a further embodiment, the metrics canbe delivered via Internet infrastructure to a portal managed by thehealthcare provider. The provider is able to adjust the device forcompression and tension to ensure the patient is receiving the bestpossible remote support.

In a further embodiment of this invention, the telemedicine subsystemincludes communication protocols to access NetMetCare. NetMetCare is atelemedicine interface comprising Internet communication protocols withvarious devices and sensors to provide remote medical care to patients,thereby avoiding office visits. It also facilitates co-operation betweenphysicians who are able to collaborate in real-time with the patient andbetween themselves. The system shall notify the patient via an alertthat the device's settings are being adjusted remotely for them by theirdoctors' office. In an aspect, NetMetCare comprises passive dataacquisition from devices and sensors in contact with a subject, e.g.,their skin, and further comprising, transmission of the acquired datavia Internet communication protocols to a server-based platform, andfurther comprising a subscription-based service and interface for healthcare providers to provide monitoring of patients, receive alerts,provide patient feedback, and the like.

In some embodiments, the orthopedic system of this invention is embodiedas footwear (e.g., a foot brace) or a footwear insert, orinterchangeably, sensors placed within footwear. It is within the scopeof this invention that the inserts are built into the shoe rather thanplaced within or are stitched within a separate sock sleeve/brace wornby the user/patient. In embodiments of this invention, one or moresensors record the load/stress at the foot of the patient so as toprovide methods and means to assess the load placed on various joints inthe human body. The joints to be assessed are either under considerationfor treatment or currently experiencing treatment for joint pain, jointsurgery, or joint replacement surgery (total and partial joint). Theorthopedic footwear device can be used alone or together with otherbraces disclosed herein, such as for monitoring/adjusting the other(e.g., knee or hip) braces.

In embodiments of this invention, the sensors are used to detect weightpatterns for non-medicinal applications and/or behavioral corrections.Without loss of generality, in addition to the medical setting asdescribed, these inserts can likewise be used by professional and“weekend warrior” athletes striving to improve their performance.Namely, in almost any sport, understanding the mechanics of the feetplays a key role in an athlete's performance. Thus, the ability toharvest data from these sensors, throughout, for example, a marathon orgolf tournament, allows trainers to measure the athlete's performanceagainst the actual stressors in their feet, knees, and hips. With thosereadings, the trainers can determine if that golfer tends to slice aball when addressing it on a downward incline. Once understood, thetrainer is able to help the golfer change the incline setup and reduce astroke or two from their game. Similarly, distance runners can improvespeed by understanding the changes in the running position of theirjoints as fatigue sets in and larger muscles start “stepping-in” tocompensate for exhausted control muscles. Succinctly, the readingsprovided by these inserts can redefine the way athletes and weekendwarriors understand how they can improve their performance in additionto minimizing short and long term injuries.

The structure and use of the orthopedic footwear device is discussedbelow primarily in terms of footwear inserts for medical treatment.However, without loss of generality, the disclosed invention operates invarious footwear and in the same manner to provide readings and guidancefor athletic or other diagnostics.

Embodiments include the ability to measure the load in the form of theweight on an injured joint based on the weight recorded on the heel,forefoot, and/or entire foot of either and/or both feet. Thus, it iswithin the scope of this invention to measure readings in the foot ofthe leg with and/or without the injured (or repaired) joint. It islikewise within the scope of this invention to record the load, namelythe weight, burdened on either or both feet of the injured leg or legsin the case of multiple injuries. The inserts may also be used tocontrast a healthy limb against that of the injured or corrected jointto allow for additional analysis of the use of the corrected joint,compensation by the healthy limb, and other factors important to thetreatment and care of injured and post-operative patients. Additionally,as aforementioned, the inserts may be used for sports training, and/ordeeper understanding of an athlete's motion and stress characteristics.

Weight applied measurements are recorded for real-time decision makingand/or later analysis using the disclosed sensors. These recorded dataenable care providers to: evaluate effects of placing weight on theafflicted joints at time periods after surgery and during intervention;develop guidelines, commonly referred to as best practices, for patientcare based on evidence-based actual weight sensor recorded and computedweight readings in addition to or in replacement of patient-reportedoutcomes only; determine proper placement/installation of an implanteddevice based on the proportional loads across the patient's feetpromptly analyze intervention effects and user behavior to expediterecovery, for example, if the patient continues to avoid puttingpressure on the joint, this could be an early indicator of potentialinfection, product defect, poorly implemented graft, etc.; analyze thestress point in the body and their impact on performance; developindividualized training guidelines for athletic performanceenhancements; and/or develop global “best practice” guidelines generatedbased from readings from multiple athletes.

FIG. 8 shows an exemplary orthopedic device according to one embodimentof this invention, which is an insert 800 that is placed into footwear,for example, a shoot or boot. In one embodiment, readings are obtainedusing an insert 800 connected to one or more computing devices (See,e.g., the telemedicine system in FIGS. 20-22) that receives measurementreadings and can transfer instructions. Communication with the computingdevice occurs via wired 802 or wireless communication. Wire connection802 can also connect to one or more other body braces, such as disclosedherein. As illustrated, the insert 800 includes an upper sole 810, alower sole 820, comfort support and placement securing foam or air 812in the upper sole 810, and gel 822 cushioning in the lower sole 820. Aswill be appreciated, various sizes, shapes, and configurations areavailable for the sole layers, depending on need.

In FIG. 8, the upper sole 810 encloses a load cell sleeve 830 includingone or more load sensors. Wire connections 802 and 832 can provide powerand/or communications. As illustrated, the cell sleeve includes a rear(heel) load sensor cell 840 (or array) and a front (forefoot) loadsensor cell 842 (or array). It is within the scope of this invention touse a plurality of cell sleeves . It is within the scope of thisinvention to have multiple load cells and cell sleeves. The rear loadsensor 840 and front load sensor 842 record the weight placed upon them,and the communication mechanisms 802 and 832 relay these readings to thecomputing device(s).

In embodiments of this invention, the cell load sensors measure theaforementioned weight/load utilizing wafer or nano load cells locatedwithin two micro-shells. These micro-shells are desirably held in one ormore, preferably cushioned, sleeve(s) 830 used to maintain the device'sposition under the foot.

FIG. 9 illustrates a representative array of load sensors. Three sensors840 are located in the heel region and five sensors 842 are located inthe forefoot region. Two additional sensors 844 are located along themiddle foot instep arch. FIG. 10 illustrates an exemplary load cell, foruse anywhere in FIG. 9, although other configurations of stress/loadcells that capture similar data are likewise within the scope of thisinvention. Each cell 850 is powered by a battery 852. In someembodiments, rather than powering via batteries, or batteries alone, thedevice, including but not limited to load cells, is powered via akinetic energy element 860 in the insert. Additionally, in oneembodiment, power would be coming from the source under the arch and notwithin each load cell. It is also within the scope of the invention touse a combination of battery cells and power generated via kineticenergy. Using batteries simplifies the design and implementation.However, maintenance and care for the device is simplified usingstrictly kinetic energy. For example, reliance on kinetic energysimplifies machine washing.

The communication of readings recorded by load cell sensors 855 to theexternal device can be provided via a low power radio transmitter,either using a single transmitter 862 in FIG. 9, and/or in each sensor850 as, for example, Bluetooth™ radio transmitter 854. A full perimetersurrounding antenna 856 can also be included. This communication systemtransmits using various communication methods known in the art,including but not limited to Bluetooth™, NFC, and other wirelessnetworking protocols. Without loss of generality, in addition to or inthe alternate, both power and communication can be accommodated via theuse of wired connections using an external connector port 858. Theentire cell is encased between bottom support 857 and top cover 859.

FIGS. 11-13 illustrate exemplary cell 840 arrays for the heel side of aninsert. For example, without loss of generality, FIG. 11 shows a singleload cell 840 that can measure the vertical force being applied to theheel. FIG. 12 shows a quad-load cell 840 array pattern that can measurethe distributed load in the heal as well as the alignment of the weightacross the heel. FIG. 13 shows a quint grouping of cell 840, which canmeasure the distribution of weight around a core vertical weight. It iswithin the scope of this invention to configure the heel with any numberof located cells. These configured cell sensor approaches and othersimilarly configured cells detect, capture, store, and provide readingsthat indicate how the heel is sticking to the ground and whether, forexample, the foot is tending to pronate or supinate. These reading, whenprovided to medical professionals, improve ailment, injury, surgery,and/or recovery assessment accuracy.

FIGS. 14-17 show exemplary array patterns for cells 842 located underthe patient's forefoot (e.g., the ball of the foot) each useable aloneor with heel sensors. FIG. 14 shows a single load cell 842 that measuresthe vertical force being applied to the forefoot. FIGS. 15 and 16 showtwo possible configurations of a triple-array of load cells 842, whichcan measure the distributed load of the inner, central, and outerforefoot, as well as the alignment of the weight across the forefoot, todetect for example super and pronation of the foot and thereby the kneeand hip. FIG. 17 shows a quint grouping of sensors 842, which canmeasure the distribution of weight across the five pressure points inthe forefoot. It is within the scope of this invention to configure theforefoot with any number of located cells, with each array being able tobe combined with any of the arrays of FIGS. 11-13. These configured cellsensor approaches and other similarly configured cells detect, capture,store, and provide readings that indicate way the forefoot is stickingto the ground and whether for example, the foot is tending to pronate orsupinate. These readings, when provided to medical professionals,improve ailment, injury, surgery, and/or recovery assessment accuracy.It is within the scope of this invention that either or both heel and/orforefoot sensors are used. It is likewise possible to combine allsensors into one composite sensor 870, such as spanning a significantportion of the foot as shown in FIG. 18.

FIG. 19 shows an exemplary orthopedic device 900 according to anotherembodiment of this invention. The device 900 includes a footbed insert905, such as shown in FIG. 8 further with an upper sleeve or brace 950into which the foot is placed. The entire device can be inserted into ashoe, or the footbed can be formed as an outsole for use without asecondary shoe. As illustrated, the footbed insert 905 includes an uppersole 910, a lower sole 920, comfort support and placement securing foamor air 912 in the upper sole 910, gel 922 cushioning in the lower sole920. Load cell sleeve 930 includes sensors 940 and 942, connected bywire 932, and wired to a power source and/or another device, such as aknee brace discussed above by wire connection 902.

The upper sleeve 950 can include any material and any sensor subsystemas discussed above for the knee or elbow brace of FIG. 1. For example,the sleeve 950 can include an assortment of sensor(s) and stimulator(s)953 in any of multiple positions. In various aspects, these sensor(s)can measure a diversity of inputs such as moisture, electric current,and sound, as discussed above. The data signal or information derivedfrom such inputs, like with other components in the orthopedic treatmentsystem, can be sent via a network to the computing device for furtherprocessing. The sleeve 950 can include a flexible ring 952, such asabout the foot or ankle, to detect swelling. The ring 952 can beembodied as discussed above, such as illustrated in FIG. 3. The sleeve950 can likewise include a compression subsystem 957 that provides atightening and loosening functionality through all or one or moresections of the sleeve 950. The compression subsystem 957 can includesystem components such as described above for FIGS. 4 and/or 5. Thecompression subsystems 957 can provide tightening across the foot, suchas being placed near or about a ‘shoelace’ position or along a side ofthe sleeve, and/or about the ankle to provide ankle support, or toloosen for swelling relief.

Using the combined data recorded by the load sensor and/or arrayslocated at the heel and/or the forefoot, a model is generated. Thismodel represents the loads and stresses brought to bear on, not only thefoot, but on affected joints. The model generated can present itsfindings, such as in an application GUI using multiple forms includingbut not limited to: the raw data outputs, the data represented andcharacterized as “hot” and “cold” spots on the under surface of thefoot, and/or an interpretation generated via an AI-driven analysis toolthat extrapolates these data recorded to provide graphicalrepresentations of the actual loads and stresses and their distributionsacross the foot. These representations could likewise, without loss ofgenerality, represent the potentially damaging stress points in otherparts on the body including for example, knees, hips, and spine.

FIGS. 20-22 illustrate a use of the orthopedic device for treatment. Theinsert and/or other sleeve or brace can be worn by the patient, andcommunicate to remote electronic device, such as computers or handhelddevices (e.g., a smartphone). The local or remote medical professionalcan monitor the weight distribution on the inserts, and make anynecessary recommendation or remote adjustment to the device(s) and/orthe treatment plan. FIGS. 21 and 22 are example GUIs that indicate thatthe left orthopedic device for a patient shows, from the sensor data, anuneven weight distribution compared to the right brace. The information,along with a recommendation from the medical professional can beprovided to the patient or a physical therapist for correction.Likewise, adjustments can be made to the braces worn by the patient(e.g., a hip or knee brace), desirably from the remote application viatelemedicine.

In embodiments of this invention, a calibration application can be runwith or in the device or on a remotely connected smartphone-like devicethat requires the patient to stand on the device on a firm floor (i.e.,not carpeted or padded in any way) to assess their actual weight andlikewise do so when the insert is placed in the shoe or other brace. Thecalibration application will assess the difference in weight in thepatient on the sleeve(s) alone versus the measurements once in thebrace. This assessment uses data from the various types of availableload cells to calculate the required offset for the use of the device byeach individual patient making the device specific to the needs of thatpatient. Note that this calibration is needed for each patient and eachbrace or shoe configuration to improve accuracy and customize thepatient specific—brace specific processing.

In yet another embodiment, the network of inserts interact with theremote device. In such an embodiment, communication is collected by auser device, such as a smartphone, connected to the sensor network via alow powered network, such as the device's “hotspot”. Via the smartphone,the readings are transferred for processing to a remote storage andprocessing facility, such as “the cloud”, and the appropriatecaretaker(s) (e.g., physician or trainer), can receive the correspondingreadings and/or analysis.

FIG. 23 shows a sleeve according to embodiments of this inventionembodied as a body suit, and particularly an infant body suit 1100. Thesleeve or body suit has an interior cavity for receiving the patient orinfant body. The body suit 1100 includes a torso section and two armsleeve sections and two leg sleeve sections, and could alternatively beembodied, for example, simply as a shirt without leg sleeve sections,arm/leg sections only, or a onesie without arm or leg sleeve sections,depending on need.

The body suit includes a pad 1101 in the center of the body suit 1100.This pad 1101 desirably includes one or more micro-charging units thatgenerate and store sufficient power to power the various sensors in thebody suit 1100 discussed below. The needed power is generated via acombination of, for example, infant body heat and breathing motion, bothconverted to energy. As only minimal energy is needed to operate thesensors incorporated in the suit 1100, the energy stored in themicrocells within the pad 1101 generally suffices. It is within thescope of this invention that alternate micro power mechanisms known inthe art can be used to power the suit components.

The body suit 1100 includes a sensor subsystem including at least onesensor integrated with the sleeve or suit, and configured to detectbreathing motion of the body and/or oxygen levels in the body. Suitablesensors include motion, temperature, moisture, pulse, circumferentialstrain gauges, and/or blood oxygen (e.g., SpO2) sensors. The sensors canbe distributed as needed throughout the suit, such as included as cuffsensors 1102 and/or waist sensors 1103 located on the cuffs (neck,ankle, and/or wrist) and waist, respectively. In some embodiments ofthis invention only some of these sensors are present. In someembodiments of this invention replications of one or more of thesesensors are present. Power is provided to these sensors via wiring 1104inlaid and distributed across the body suit 1100 as needed.

In some embodiments of this invention, adhesives or fasteners 1105, suchas but not limited to hook and loop fasteners (Velcro®), snaps, etc.,are attached to both sides of the arm sleeves to secure the arms to thechest. Initially, one arm, as shown in FIG. 23, can be attached to thepad 1101 using the inner fastener 1105 of the arm, and then the innerfastener 1105 of the other arm can be attached to an outer fastener 1106of the first arm, as shown in FIG. 24. Desirably, either arm can beattached to the pad 1101 and to each other. Thus, the right or the leftarm can be placed underneath the other and attached to the pad 1101. Itis also within the scope of this invention for both arms to be directlyconnected via their respective inner fasteners 1105 to the pad 1101.

The sensors of the body suit 1100 desirably communicate via a local,low-powered network, such as, but not limited to Bluetooth®, with astartle mechanism configured to actuate upon a detection of apredetermined event that indicates an issue with the patient or infant.The predetermined event typically is selected from slowed or stoppedbreathing and/or an oxygen level below a predetermined amount. Thesystem can also monitor for other potential issue-indicating eventsknown in the art, and used for a startle mechanism, depending on need.The startle mechanism can include any one or more of various physicalstartling techniques to awaken, either partially or fully, the patientor infant. Exemplary startle mechanisms include, without limitation, anagitating component or support, an audio stimulation (e.g., speakersubsystem), an electrical stimulation, a temperature stimulation, apressurized air stimulation, or combinations thereof. The systemtypically includes a controller, separate to or integrated with thesensor subsystem or startle mechanism, for controlling these componentsand the communication there between.

In embodiments of this invention, the startle mechanism, desirably alongwith any controller, is incorporated within or otherwise in combinationwith a patient support configured to support the patient or infant bodythereon. In some preferred embodiments of this invention, the patientsupport agitates the body thereon upon the detection of thepredetermined event. The agitation can be, without limitation, avibration, such as from a vibrating support or component, and/or a dropcomponent, such as the drop platform configured to support the body anddrop suddenly in a controlled manner upon the detection of thepredetermined event. The support can alternatively or additionallyinclude a speaker system for an audio startle stimulation. These, orother startle mechanisms, can be used in various combinations, forexample, at the same time or sequentially, such as in increasingintensity.

Embodiments of the patient support of this invention include a dropplatform as a startle mechanism. Via a communications port, a controllerhoused in the platform receives and monitors in real-time all sensorreadings and determines if a response is needed. If deemed necessary,the controller initiates a platform drop and triggers any and/or allauxiliary startle mechanisms (sound, temperature, pricks, forced air,etc.) as described hereafter.

FIG. 25 generally illustrates a SIDS prevention encasement 1200,according to one embodiment of this invention. The encasement 1200includes a drop platform 1210. The devices includes the necessary powerrelated components, such as an A/C power outlet box 1230, where a powerchord is stored when not in use, a power source 1231, a backup batterypower source 1241, and a backup battery charger 1240. The enclosurefurther includes a speaker panel 1220, as an alternative or additionalstartle mechanism.

The drop platform 1210, upon detection of need, rapidly drops to startleand awaken the infant placed thereon. The speakers 1220 can additionallyblast loud sounds, preferably in a seemingly flowing and moving pattern,that likewise scare and awaken the child. Both the loud noise and thesudden drop serve as startle mechanisms to startle and awaken theinfant, instinctively forcing the infant to cry and ingest air.

FIG. 26 illustrates an encasement 1200 resting on top of a stand 1300.As shown, the encasement 1200 is secured via a metal hole joint 1303built into the stand 1300, which connects to a metal ball 1302 that ispart of the folding short legs of the encasement 1200. The stand legs1301 are preferably adjustable as shown in FIG. 13, providing thecaregiver easier access and greater convenience. As shown, theencasement 1200 is self-contained; hence portability, namely removalfrom the resting base 1300 is provided by preferred embodiments. Forexample, the self-contained encasement 1200 can likewise be placed ontop of a bed 1400, as shown in FIG. 27.

Exemplary components of a SIDS prevention encasement 1200 according toembodiments of this invention are illustrated in FIG. 28. Asillustrated, a graphite speaker is used as the speaker panel 1220, butother speaker options known in the art, such as but not limited to a setof linearly arranged speakers, are likewise within the scope of thisinvention. A desirable effect the speaker panel 1220, according toembodiments of this invention, is to produce a blast of loud sounds in aseemly flowing and moving pattern. FIG. 28 also illustrates possiblepositions of the drop platform 1210 according to embodiments of thisinvention. Initially, the child is placed on the platform 1210, such asat an inclining position. The degree of the incline must be sufficientlyhigh to support a sudden drop but not too high as to result in theinfant sliding down the incline. Upon the controller determining that itis necessary to awaken the infant, the platform 1210 rapidly drops,startling and awakening the infant as intended. Simultaneously, loudsounds from the speaker panel 1220 can commence. Loud sounds likewiseindirectly notify the infant caregiver of a potential problem.

Care must be taken to properly design the rapidly dropping platform1210, because too harsh of a landing could harm the child. FIGS. 29 and30 show a pulley 1214, controlled by the controller that allows the dropplatform 1210 to provide a soft landing. As shown in FIG. 29, theplatform 1210 is designed to fall at a non-limiting exemplary rate of30.5 meters per second until a predetermined height. At that height,indicated as the start of the break zone, the pulley 1214 driving thedrop rapidly decelerates to nearly a complete stop leading the platform1210 to a gentle rest on the base of the encasement 1200. The initiallyinclined and the post-drop resting positions of the drop platform 1210are representatively illustrated in FIGS. 29 and 30.

FIG. 31 shows a motor 1211, gearbox 1212, and drive shaft 1213 fordriving and controlling the pulley 1214 system as dictated by thecontroller. The motor 1211 is programmed to rapidly accelerate andrapidly decelerate the gearbox 1212 rotating the shaft 1213 so as tocreate a rapid drop and a comfortable landing for the drop platform 1210once it is determined by the controller that a drop is needed.

FIG. 32 illustrates an end view of a SIDS prevention encasement 1200,according to embodiments of this invention. An optional fan system 1252prevents potential carbon dioxide buildup by the infant's face. Byinducing air circulation within the encasement 1200, particularly apartially or fully enclosed encasement, the potential for residualcarbon dioxide is reduced. As shown, fans 1252 inserted into theopenings in the front panel 1250 are powered by motor 1251. Ventopenings in the sides and/or opposing end of the encasement 1200 enablethe flow of air out of the encasement 1200. Variable positioned slits1253 further support air circulation.

Alternative or additional startle mechanisms can be included to interactwith the body sleeve system to awaken the infant and thereby preventSIDS. Embodiments of this invention include mechanisms incorporated in awearable item, such as integrated within the sleeve itself, a separateclothing item, and/or a footwear apparatus. FIGS. 33-36 each illustratea footwear (e.g., shoe) startle mechanism according to embodiments ofthis invention. These shoes 1500 awaken the child by, for example, anelectrical stimulation mechanism, a temperature stimulation mechanism, apressurized air stimulation mechanism, or combinations thereof. Asshown, these approaches all rely on shoes added to or in combinationwith the body sleeve 1100 of FIG. 23. Although annoying to the infant,hence providing an awakening event, none of these prescribed approachesactually harm the infant as their dosages are low and their directcontact with the infant is protected.

Each of FIGS. 33-36 shows a view an infant awakening shoe 1500. Multipleinstantiations of such shoe 1500 exist. In all embodiments presented, apower source 1501, herein represented by a non-limiting example of abattery 1501, is needed to activate an annoying, and hence awakening,substrate 1502-1505, for example, as the side/top and/or sole of theshoe 1500. A controller within the shoe 1500 communicates with the maincontroller in the infant body suit 1100, triggers an awakening responsewhen needed.

In one embodiment, if deemed necessary, the infant is awakened via mildelectric impulses or shocks. These shocks are similar but not limited tothose potentially delivered by a 9 Volt DC battery. The mild shocks areintroduced to both feet via the electrically stimulated bars 1502 withinthe shoe 1500 shown in FIG. 33. In another embodiment, instead ofintroducing an electric shock to both feet, a sudden cold of freezingtemperature is introduced. The sudden freezing is introduced via icingtemperature bars 1503 in FIG. 34. In yet another embodiment, instead ofintroducing an electric shock or freezing temperatures to both feet,sudden pricks via pressurized compressed air through vent holes 1504 inFIG. 35 or built in pins 1505 in FIG. 36 are introduced. All of theseapproaches awaken the infant, yielding the desired effect. Likewisewithin the scope of this disclosure is combining multiple of thesestimulants into a single shoe.

Thus the invention provides various embodiments of body supports,monitoring, and/or treatment devices and systems. The incorporation ofvarious sensors or other active systems provide improved treatment,which can be monitored and controlled locally or remotely.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the present disclosurewithout departing from the scope or spirit of the disclosure. Otheraspects of the disclosure will be apparent to those skilled in the artfrom consideration of the specification and practice of the disclosuredisclosed herein. It is intended that the specification and examples beconsidered as exemplary only, with a true scope and spirit of thedisclosure being indicated by the following claims.

What is claimed is:
 1. A support and/or treatment system, comprising: anorthopedic footbed adapted to be worn by a patient; a footbed sensorintegrated with the orthopedic footbed, and configured to measure a loadand/or weight thereon; and a control device remote from the orthopedicfootbed and connected to the footbed sensor over a network, wherein thecontrol device is configured to measure and model stress in a foot,knee, and/or hip of the patient.
 2. The system of claim 1, wherein thefootbed sensor comprises an array of load cells in at least one of aheel location or a forefoot location of the orthopedic footbed.
 3. Thesystem of claim 2, wherein the array of load cells comprises a quintarray including four corner load cells about a center load cell.
 4. Thesystem of claim 1, further comprising a low power wireless transmitterdisposed within the orthopedic footbed, and in communication with thecontrol device.
 5. The system of claim 4, wherein the low power wirelesstransmitter is configured to send readings to a connected smartphone andthe smartphone comprising an application that stores readings locallyand transmits the readings to a remote cloud server.
 6. The system ofclaim 1, further comprising a power subsystem integrated with theorthopedic footbed, and comprising a kinetic energy source configured togenerate power from movement of the orthopedic footbed.
 7. The system ofclaim 1, wherein the orthopedic footbed comprises a brace or a sleeveconfigured to extend about a foot of the patient.
 8. The system of claim7, further comprising a further sensor subsystem integrated with theorthopedic footbed or the brace or the sleeve, and in communication withthe control device, wherein the sensor subsystem comprises a pulsesensor, a blood flow sensor, a blood pressure sensor, an oxygen sensor,a temperature sensor, an electric sensor, a moisture sensor, abiological/chemical sensor, a range of motion sensor, acompression/resistance sensor, a circumferential strain gauge, orcombinations thereof.
 9. The system of claim 8, wherein the sensorsubsystem comprises the electric sensor configured to determine muscularmicro-electrical activity.
 10. The system of claim 8, wherein the sensorsubsystem comprises a flexible ring integrated with the brace or sleeveand configured to be disposed about the foot, and at least one sensoradapted to measure swelling in the foot within the ring.
 11. The systemof claim 7, wherein the adjustment mechanism comprises a compressionsubsystem integrated with the brace or the sleeve and having variabletension controllable by the control device via the control unit.
 12. Thesystem of claim 11, wherein the compression subsystem comprises arotating rod and a motor configured to rotate the rotating rod to adjusta compression or tension in the brace or the sleeve.
 13. The system ofclaim 12, wherein the compression or tension is automatically monitoredby the sensor subsystem and automatically adjustable by the controldevice.
 14. The system of claim 11, further comprising: a rotatable rodincluding a flexible center section between two rigid end sections; anda plurality of straps each connected at a first end to the rotating rodand fixed at a second end to the compression subsystem, wherein rotationof the bar tightens or loosens the straps.
 15. The system of claim 1,wherein the control device communicates with the footbed sensor througha control unit of a second orthopedic device simultaneously worn on thepatient.
 16. The system of claim 1, further comprising: a knee brace orsleeve including a support structure and an interior cavity configuredto receive a knee of the patient; a flexible ring integrated with theknee brace or sleeve and encircling the interior cavity, the flexiblering including a plurality of sensors adapted to measure swelling in theknee within the interior cavity; an adjustment mechanism in combinationwith the support structure, wherein the adjustment mechanism adjusts atension in at least a portion of the support structure; a control unitincluding a processor integrated with the knee brace or sleeve and incontrol combination with the adjustment mechanism to adjust the tensionof the support structure; and wherein the control device is remote fromthe brace or sleeve and connected to the control unit over a network.17. The system of claim 16, wherein the control device communicates withthe footbed sensor through the control unit of the knee brace or sleevesimultaneously worn on the patient.
 18. The system of claim 16, whereinthe adjustment mechanism comprises a rotating bar or rod and two motorseach at an opposing end of the rotating bar or rod and controllable bythe control device via the control unit, and the rotating bar or rodcomprises a flexible center section between two rigid end sections, andwherein the two motors are configured to rotate the rigid end sectionsin opposing rotational directions to adjust the tension within thesupport structure.
 19. The system of claim 16, the adjustment mechanismcomprises a rotating bar or rod and two motors each at an opposing endof the rotating bar or rod and controllable by the control device viathe control unit, and further comprising a plurality of straps eachconnected at a first end to the rotating bar or rod and fixed at asecond end to the brace or sleeve, wherein rotation of the bar or rodtightens or loosens the straps to adjust a tension of the interiorcavity.
 20. The system of claim 1, further comprising: a knee supportbrace adapted to be worn by the patient; a control unit including aprocessor integrated with the knee support brace, wherein the controldevice is a telemedicine control device remote from the knee supportbrace and connected to the control unit and the footbed sensor over thenetwork; an adjustment mechanism integrated with the knee support brace,wherein the control unit is in controlling combination with theadjustment mechanism, and the adjustment mechanism comprises acompression subsystem integrated with the knee support brace and havingvariable tension controllable by the telemedicine control device via thecontrol unit, the compression subsystem comprises: a rotating bar or rodand a motor configured to rotate the rotating bar or rod to adjust acompression or tension in the knee support brace, and a plurality ofstraps each connected at a first end to the rotating bar or rod andfixed at a second end to the brace or sleeve, wherein rotation of therotating bar or rod tightens or loosens the plurality of straps toadjust compression of the brace or sleeve about an internal cavity ofthe brace or sleeve; a sensor subsystem integrated with the knee supportbrace and in communication with the control unit, wherein thecompression or tension is automatically monitored by the sensorsubsystem and automatically adjustable by the control unit, and whereinthe sensor subsystem comprises a first flexible ring integrated with theknee support brace, encircling the internal cavity of the brace orsleeve, and with at least one sensor adapted to measure swelling in abody part within the first flexible ring and the knee support brace; andwherein the telemedicine control device is accessible by a remotelylocated telemedicine healthcare provider to receive metrics from thefootbed sensor and the control unit and for control and adjustment ofthe adjustment mechanism and the knee support brace throughout treatmentof the patient by the telemedicine healthcare provider via the kneesupport brace.
 21. A support and/or treatment system, comprising: afirst orthopedic device comprising a knee support brace adapted to beworn by a patient; a control unit including a processor integrated withthe first orthopedic device; a telemedicine control device remote fromthe first orthopedic device and connected to the control unit over anetwork; an adjustment mechanism integrated with the first orthopedicdevice, wherein the control unit is in controlling combination with theadjustment mechanism, and the adjustment mechanism comprises acompression subsystem integrated with the first orthopedic device andhaving variable tension controllable by the telemedicine control devicevia the control unit, the compression subsystem comprises: a rotatingbar or rod and a motor configured to rotate the rotating bar or rod toadjust a compression or tension in the first orthopedic device, and aplurality of straps each connected at a first end to the rotating bar orrod and fixed at a second end to the brace or sleeve, wherein rotationof the rotating bar or rod tightens or loosens the plurality of strapsto adjust compression of the brace or sleeve about an internal cavity ofthe brace or sleeve; a sensor subsystem integrated with the firstorthopedic device and in communication with the control unit, whereinthe compression or tension is automatically monitored by the sensorsubsystem and automatically adjustable by the control unit, and whereinthe sensor subsystem comprises a first flexible ring integrated with thefirst orthopedic device, encircling the internal cavity of the brace orsleeve, and with at least one sensor adapted to measure swelling in abody part within the first flexible ring and the first orthopedicdevice; a second orthopedic device comprising an orthopedic footbedadapted to be worn by a patient; a footbed sensor integrated with theorthopedic footbed, and configured to measure a load and/or weightthereon, wherein the telemedicine control device is remote from thesecond orthopedic device and connected to the footbed sensor over thenetwork; wherein the telemedicine control device is accessible by aremotely located telemedicine healthcare provider to receive metricsfrom the control unit and the footbed sensor, and for control andadjustment of the adjustment mechanism and the first orthopedic devicethroughout treatment of the patient by the telemedicine healthcareprovider via the first orthopedic device.